Sitagliptin in Non-Diabetic Patients Undergoing General Surgery

Emory University

Status and phase: Completed; Phase 4

Conditions: Hyperglycemia

Treatments: Drug: Supplemental insulin (insulin aspart); Drug: Long acting basal insulin (insulin glargine); Drug: Placebo; Drug: Supplemental insulin (insulin lispro); Drug: Sitagliptin; Drug: Long acting basal insulin (insulin detemir)

Study type: Interventional

Funder types: Other

Identifiers

NCT02741687

IRB00087357

Details and patient eligibility

About

The purpose of this study is to compare sitagliptin with a placebo for the prevention of high glucose after general surgery.

Full description

Approximately 30-40% of hospitalized patients will develop stress hyperglycemia (high glucose in response to surgery or illness). High glucose is linked to an increased risk of hospital complications including wound infection, kidney failure and death. Patients with high glucose are treated with insulin given through an arm vein or by frequent insulin injections under the skin. Recent studies have found that inpatient therapy with oral dipeptidyl peptidase-4 inhibitor (DPP4-I) is an effective alternative to insulin in improving glycemic control with low risk of hypoglycemia in general medicine and surgical patients.

Sitagliptin is an oral medication approved by the Food and Drug Administration (FDA) to treat patients with diabetes. The aim of this study is to determine whether treatment with sitagliptin once daily can prevent the development of stress hyperglycemia during the postoperative period in non-diabetic patients undergoing general surgery.

Enrollment: 80 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Undergoing non-cardiac surgery
• No previous history of diabetes or hyperglycemia
• Fasting blood glucose level of <126 mg/dl
• Blood glucose <126mg/dl at the time of randomization (could occur at any time of the day)

Exclusion criteria

• History of hyperglycemia (blood glucose equal to or above 126 mg/dl or HbA1C greater than 6.5%) or previous treatment with oral antidiabetic agents or insulin
• Patients undergoing cardiac surgery
• Patients anticipated to require ICU care following surgery
• Severely impaired renal function (GFR < 30 ml/min) or clinically significant hepatic failure
• Moribund patients and those at imminent risk of death (brain death or cardiac standstill)
• Patients with gastrointestinal obstruction or adynamic ileus or those expected to require gastrointestinal suction
• Patients with clinically relevant pancreatic or gallbladder disease
• Treatment with oral (> 5 mg/day) or injectable corticosteroid
• Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
• Pregnancy or breast-feeding at time of enrollment

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Sitagliptin Arm

Experimental group

Description:

Participants will receive sitagliptin beginning the day prior to surgery and continuing daily during hospitalization (up to 10 days post-surgery). Point of care (POC) testing will be done four times daily, before meals and at bedtime, or every 6 hours for patients who are not eating (NPO). Patients developing hyperglycemia during or after surgery will be treated with insulin per standard of care. Patients with fasting and/or premeal blood glucose levels \>180 mg/dl will receive supplemental insulin provided on a sliding scale. Patients with two consecutive fasting and/or premeal blood glucose levels \>180 mg/dl, or with average daily blood glucose levels \>180 mg/dl will be started on rescue therapy with subcutaneous insulin once daily plus correction doses by a sliding scale.

Treatment:

Drug: Sitagliptin

Drug: Supplemental insulin (insulin aspart)

Drug: Long acting basal insulin (insulin glargine)

Drug: Long acting basal insulin (insulin detemir)

Drug: Supplemental insulin (insulin lispro)

Placebo Arm

Placebo Comparator group

Description:

Participants will receive a placebo tablet beginning the day prior to surgery and continuing daily during hospitalization (up to 10 days post-surgery). Point of care (POC) testing will be done four times daily, before meals and at bedtime, or every 6 hours for patients who are not eating (NPO). Patients developing hyperglycemia during or after surgery will be treated with insulin per standard of care. Patients with fasting and/or premeal blood glucose levels \>180 mg/dl will receive supplemental insulin provided on a sliding scale. Patients with two consecutive fasting and/or premeal blood glucose levels \>180 mg/dl, or with average daily blood glucose levels \>180 mg/dl will be started on rescue therapy with subcutaneous insulin once daily plus correction doses by a sliding scale.

Treatment:

Drug: Supplemental insulin (insulin aspart)

Drug: Long acting basal insulin (insulin glargine)

Drug: Long acting basal insulin (insulin detemir)

Drug: Supplemental insulin (insulin lispro)

Drug: Placebo